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Contract Manufacturing: Validation

By Ellie Nixon | 24th August 2022

All of our in vitro diagnostic medical devices comply with the latest regulations, making us the number one choice for our customers.

At Hart Biologicals we are committed to meet the highest industry standards and are backed by a strong team of medical device regulators. We make it our top priority to not only to ensure that all of our products are of the highest quality, but that all of the products we produce are compliant to all relevant regulations.

To give our customers a higher level of reassurance, we are ISO 13485:2016 certified, giving our customers the reassurance, they want that the products are made effective and safe for their patients. We deal with customers from all over the world and we adhere to the Title 21 of FDA CFR Part 820, and follow the regulations stated in EU 2017/746 (EU IVDR). We fully comply with EU IVDR and has CE marking on their products. To ensure the compliance and safety we send the product technical documentation for conformity assessments by a notified body as well.

These comprehensive quality management systems cover the development, manufacturing, sales, and distribution of In Vitro Testing medical devices. We meet the top standards in the industry of vitro diagnostics medical devices and our industry expertise enables us to provide our contract manufacturing partners with product validation documentation for every stage of the journey, internal regulatory support and clinical validation activity for full life-cycle support.

Hart always ensures quality and reduces time-to market.

Partnering with Hart Biologicals means that you will receive not only high-quality products, but expert support from our team, who are always here for you to provide expert advice and support on an on-going basis.

Our products are provided with everything you need: documentation, instructions and bespoke packaging as standard.


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To find out more about contract manufacturing, click here